Global Uterine Fibroids Clinical Landscape Market Report 2021 - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Market Spotlight: Uterine Fibroids" report has been added to ResearchAndMarkets.com's offering.

This Market Spotlight report covers the Uterine Fibroids market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

The publisher estimates that in 2019, there were approximately 94.9 million prevalent cases of uterine fibroids worldwide in females aged 15 years and over, and forecasts that number to increase to 105.0 million prevalent cases by 2028.

Lupron, Orgovyx, and ORIAHNN, which target gonadotropin-releasing hormone receptor, and ulipristal acetate, which targets progesterone receptor, are the only approved drugs for uterine fibroids. These drugs are administered via the oral and subcutaneous routes.

The largest proportion of industry-sponsored drugs in active clinical development for uterine fibroids are in Phase III, with one drug in the NDA/BLA phase.

Therapies in development for uterine fibroids focus on targets such as progesterone receptor, gonadotropin-releasing hormone receptor, and collagen. The majority of pipeline drugs are administered via the oral route, with one product being developed in a subcutaneous formulation.

High-impact upcoming events for drugs in the uterine fibroids space comprise expected CHMP opinions for Yselty and Orgovyx, as well as a PDUFA date for Orgovyx.

The overall likelihood of approval of a Phase I gynecology asset is 14%, and the average probability a drug advances from Phase III is 70%. Drugs, on average, take 11.8 years from Phase I to approval, compared to 13.0 years in the overall obstetrics/gynecology space.

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for uterine fibroids have been in the early and mid-phases of development, with 60% of trials in Phase I-II, and 40% in Phase III-IV.

The US has a substantial lead in the number of uterine fibroids clinical trials globally. The UK leads the major European markets, while Japan has the top spot in Asia.

Clinical trial activity in the uterine fibroids space is dominated by completed trials. Repros Therapeutics has the highest number of completed clinical trials for uterine fibroids, with 17 trials.

Key Topics Covered:

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

• Subtypes

TREATMENT

• Surgery
• Medical agents

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

• Yselty for Uterine Fibroids (July 6, 2020)
• Yselty for Uterine Fibroids (December 9, 2019)
• Orgovyx for Uterine Fibroids (July 23, 2019)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

• FDA Emphasizes Benefits And Risks, Gives Containment System Warning In LPM Final Guidance
• EMA's CHMP Makes Decision On Esmya
• EMA Safety Panel Recommends Withdrawing Esmya Authorizations
• Myovant's Relugolix Chases AbbVie's Elagolix In Women's Health Market
• FDA Approves First Medical Treatment For Fibroid-Related Heavy Menstrual Bleeding
• Myovant Sciences' Relugolix Among 14 New Hopefuls At EMA
• Ulipristal Suspended In EU Pending Further Review
• FDA Recommends Further Limiting Use Of Laparoscopic Power Morcellation

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

• Pfizer Gains New Commercial Drug Orgovyx In Deal With Myovant
• Hologic Acquires Acessa To Add ProVu Fibroid Treatment
• Myovant Licenses Ex-US Relugolix Rights To Gedeon Richter

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

• Sponsors by status
• Sponsors by phase
• Recent events

BIBLIOGRAPHY

• Prescription information

APPENDIX

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